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The updated analysis, conducted by Eric J Small, MD, of the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, and collaborators, looked at second progression-free survival (PFS2) — defined as the time from randomization, through the development of metastases, until disease progression on subsequent anticancer therapy or death — and safety after 1 year of additional follow-up. The median treatment duration with apalutamide and placebo was 25.7 months and 11.5 months, respectively. (In the original analysis, the median treatment duration was 19.2 and 11.2 months, respectively.)

Compared with the placebo group, the apalutamide group had a significant 50% decreased risk of PFS2 (hazard ratio [HR] 0.5; 95% CI, 0.39-0.63; P <.0001). The median time to PFS2 was not reached in the apalutamide arm and was 39.3 months among placebo recipients.

“These data suggest that earlier treatment, prior to the development of overt metastases, is likely to provide an advantage over delaying therapy until metastases develop,” Dr Small said in an interview with Cancer Therapy Advisor.

In addition, at a median follow-up of 32 months, 51.3% of patients in the apalutamide group, 8% of the 75 patients who crossed over from the placebo to the apalutamide group, and 99.7% of remaining placebo recipients had discontinued study treatment.

Rates of discontinuation due to progressive disease and adverse events (AEs) were 27.3% and 12.7%, respectively, in apalutamide-treated patients and 73.4% and 8.4%, respectively, in the placebo arm. Dr Small’s team found no substantial change in the incidence of treatment-emergent AEs in the apalutamide group at the 1-year update, despite a longer exposure time to apalutamide.

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